pancreatic cancer
Conditions
Interventions
Experimental group:Nituzumab combined with AG regimen for neoadjuvant chemotherapy transformation therapy
Sponsors
Harbin Medical University Affiliated Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, including 18 and 75 years; 2. ECOG PS score 0-2; 3. Patients with stage III-IV pancreatic cancer diagnosed by histopathology or cytology. If the patient refuses to puncture or the pancreatic pathological puncture is difficult, PET-CT, nuclear magnetic resonance, tumor markers (CA199, CA125, CEA) and other relevant evidence are required to support. (according to the 2020 CSCO Guidelines for the Diagnosis and Treatment of Pancreatic Tumors); 4. There is no distant metastasis in imaging assessment; 5. Imaging assessment of lesions involving the superior mesenteric artery or superior mesenteric vein, the extent of invasion = 12 months; 9. Hematological indicators are basically normal: white blood cell count >=4x10^9/L; absolute neutrophil count >=1.5x10^9/L; platelets >=100x10^9/L; hemoglobin >=90 g/L; 10. Basically normal renal function: serum creatinine=60mL/min; 11. The liver function is basically normal: serum total bilirubin <=1.5xULN (if liver metastasis is present, serum total bilirubin should be <=3.0xULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5xULN (<=5.0xULN, if there is liver metastasis); 12. Sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have received radiation therapy, chemotherapy, monoclonal antibody and oral EGFR-TKI therapy, anti-angiogenesis drugs, and immunosuppressants within half a year; 2. Participated in other interventional clinical trials within 30 days before screening; 3. History of other malignant tumors (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignant tumors that have been cured for more than 5 years); 4. There are concurrent diseases that are poorly controlled (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.); 5. Known HIV infection or active viral hepatitis; 6. Are receiving chronic steroid therapy for more than 6 months (such as prednisone dose > 10 mg/day or equivalent dose); 7. Those who are allergic to the drugs or their components used in this program; 8. According to the criteria of Common Adverse Event Terms (NCI CTCAE V5.0), >= grade 2 peripheral nerve disease or hearing loss; 9. Pregnant women (confirmed by blood or urine HCG test) or lactating women, or subjects of childbearing age are unwilling or unable to take effective contraceptive measures (both male and female subjects) until at least 6 months after the last trial treatment; 10. The researcher believes that it is not suitable to participate in the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor complete response rate;Objective response rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactZhang Songyan
Harbin Medical University Affiliated Tumor Hospital
Outcome results
None listed